Development of a pregnancy-specific reference material for thyroid biomarkers, vitamin D, and nutritional trace elements in serum.

Autor:	Boggs ASP; National Institute of Standards and Technology, Hollings Marine Laboratory, Charleston, SC, USA., Kilpatrick LE; National Institute of Standards and Technology, Gaithersburg, MD, USA., Burdette CQ; National Institute of Standards and Technology, Gaithersburg, MD, USA., Tevis DS; Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA, USA., Fultz ZA; Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA, USA., Nelson MA; National Institute of Standards and Technology, Gaithersburg, MD, USA., Jarrett JM; Division of Laboratory Sciences, National Center for Environmental Health, Centers for Disease Control and Prevention, Atlanta, GA, USA., Kemp JV; Division of Clinical Biochemistry and Immunology, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA., Singh RJ; Division of Clinical Biochemistry and Immunology, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA., Grebe SKG; Division of Clinical Biochemistry and Immunology, Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.; Division of Endocrinology, Department of Medicine, Mayo Clinic, Rochester, MN, USA., Wise SA; National Institute of Standards and Technology, Gaithersburg, MD, USA.; National Institutes of Health, Office of Dietary Supplements, Bethesda, MD, USA., Kassim BL; National Institute of Standards and Technology, Hollings Marine Laboratory, Charleston, SC, USA., Long SE; National Institute of Standards and Technology, Hollings Marine Laboratory, Charleston, SC, USA.
Jazyk:	angličtina
Zdroj:	Clinical chemistry and laboratory medicine [Clin Chem Lab Med] 2020 Oct 26; Vol. 59 (4), pp. 671-679. Date of Electronic Publication: 2020 Oct 26 (Print Publication: 2021).
DOI:	10.1515/cclm-2020-0977
Abstrakt:	Objectives: Matrix differences among serum samples from non-pregnant and pregnant patients could bias measurements. Standard Reference Material 1949, Frozen Human Prenatal Serum, was developed to provide a quality assurance material for the measurement of hormones and nutritional elements throughout pregnancy. Methods: Serum from non-pregnant women and women in each trimester were bottled into four levels based on pregnancy status and trimester. Liquid chromatography tandem mass spectrometry (LC-MS/MS) methods were developed and applied to the measurement of thyroid hormones, vitamin D metabolites, and vitamin D-binding protein (VDBP). Copper, selenium, and zinc measurements were conducted by inductively coupled plasma dynamic reaction cell MS. Thyroid stimulating hormone (TSH), thyroglobulin (Tg), and thyroglobulin antibody concentrations were analyzed using immunoassays and LC-MS/MS (Tg only). Results: Certified values for thyroxine and triiodothyronine, reference values for vitamin D metabolites, VDBP, selenium, copper, and zinc, and information values for reverse triiodothyronine, TSH, Tg, and Tg antibodies were assigned. Significant differences in serum concentrations were evident for all analytes across the four levels (p≤0.003). TSH measurements were significantly different (p<0.0001) among research-only immunoassays. Tg concentrations were elevated in research-only immunoassays vs. Federal Drug Administration-approved automated immunoassay and LC-MS/MS. Presence of Tg antibodies increased differences between automated immunoassay and LC-MS/MS. Conclusions: The analyte concentrations' changes consistent with the literature and the demonstration of matrix interferences in immunoassay Tg measurements indicate the functionality of this material by providing a relevant matrix-matched reference material for the different stages of pregnancy. (© 2020 Walter de Gruyter GmbH, Berlin/Boston.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu